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ISO 10993-23:2021

Biological evaluation of medical devices — Part 23: Tests for irritation

Jan 20, 2021

General information

90.20     Jan 15, 2026

ISO

ISO/TC 194

International Standard

11.100.20  

English   French  

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Scope

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2.
This document includes:
— pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;
— details of in vitro and in vivo irritation test procedures;
— key factors for the interpretation of the results.

Life cycle

NOW

PUBLISHED
ISO 10993-23:2021
90.20 Standard under periodical review
Jan 15, 2026

CORRIGENDA / AMENDMENTS

PUBLISHED
ISO 10993-23:2021/Amd 1:2025

REVISED BY

PROJECT
ISO/PWI 10993-23

National adoptions

SRPS EN ISO 10993-23:2021  
ISS

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

60.60   Standard published

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